Catheter assembly

ABSTRACT

A catheter assembly includes: a hollow catheter; a catheter hub to which the catheter is fixed; an inner needle including a needle tip, the inner needle being detachably disposed inside of the catheter; a needle hub to which the inner needle is fixed; a catheter operation member configured to move the catheter relative to the inner needle; and a support member disposed at the needle hub and configured to rotate about a rotation axis orthogonal to a longitudinal direction of the assembly. The support member includes a support main body portion that projects in a direction orthogonal to the rotation axis of the support member and that is movable relative to the needle hub between (i) a first position at which the support main body portion contacts and supports the catheter, and (ii) a second position at which the support main body portion does not contact the catheter.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/412,144, filed May 14, 2019, which is a continuation of U.S. patentapplication Ser. No. 15/296,683, filed on Oct. 18, 2016 (issued as U.S.Pat. No. 10,335,578, on Jul. 2, 2019), which is a bypass continuation ofPCT Application No. PCT/JP2016/063914, filed on May 10, 2016, whichclaims priority to Japanese Application No. 2015-100357, filed on May15, 2015. The entire contents of which are hereby incorporated byreference in their entireties.

BACKGROUND

The present disclosure relates to a catheter assembly adapted topuncture a blood vessel and be indwelled at the time of performinginfusion or the like to a patient, for example.

In the related art, a catheter assembly is used at the time ofperforming infusion or the like to a patient. This kind of the catheterassembly includes a hollow catheter, a catheter hub fixed to a proximalend of the catheter, a hollow inner needle inserted into the catheterand having a sharp needle tip at a distal end, and a needle hub fixed toa proximal end of the inner needle (refer to JP 2013-529111 A).

In the catheter assembly disclosed in JP 2013-529111 A, because thecatheter is inserted deep into the patient's body, the long catheter andthe inner needle are housed in an axial direction of the inside of thecylindrical-shaped needle hub in a stacking manner. A user such as adoctor or a nurse punctures the patient with the catheter and the innerneedle, and performs an advancing operation of a catheter operationmember connected to the catheter hub in this puncturing state, therebymaking the long catheter advance relative to the inner needle and theneedle hub and inserting the same into the body.

SUMMARY

The above-described type of a catheter assembly has a structure in whicha distal end side of a needle hub is separated into upper and lowerportions at the time inserting a catheter into the inside of a body, anda catheter, a catheter hub, and a catheter operation member are detachedfrom an inner needle and the needle hub after insertion of the catheter.However, in the structure in which the needle hub is thus separated, thecatheter and the inner needle extend relative to the needle hub in anon-supported (free) state at the time of inserting the catheter, thecatheter is relatively easily warped when reaction force is receivedfrom a patient. Depending on the case, a needle tip may retract (slipout) from an inserted portion of the patient and the patient may bepunctured again with the needle tip.

Embodiments of the present invention have been made in view of theabove-described situation, and are directed to providing a catheterassembly in which a catheter is prevented from being warped by enablingsupport for the catheter at the time of inserting the catheter, andfurthermore, a catheter hub and a catheter operation member can beeasily detached from a needle hub.

In order to achieve the above-described objects, a catheter assemblyaccording to one embodiment of the present invention includes: a hollowcatheter; a catheter hub adapted to fix and hold the catheter; an innerneedle including a needle tip and adapted to be detachably insertedthrough inside of the catheter; a needle hub configured to fix and holdthe inner needle; a catheter operation member capable of moving thecatheter relative to the inner needle; and a support member provided atthe needle hub. The support member includes a support main body portionthat is movable between (i) a first position located on a side of thecatheter opposite the catheter operation member, at which the catheteris interposed between the support member and the catheter operationmember and the support main body portion contacts and supports thecatheter, and (ii) a second position that is a different position fromthe first position, at which the support main body portion does notcontact the catheter.

According to above embodiment, the catheter assembly can support thecatheter with the support member located at the first position on anopposite side of the catheter operation member. Therefore, at the timeof advancing operation of the catheter operation member, the supportmember contacts and supports the catheter inside the needle hub and canprevent the catheter from being warped even in the case where thecatheter receives reaction force from a patient. Consequently, anextending state of the catheter and the inner needle is maintained, anda user can smoothly insert the catheter into the patient. Furthermore,the support member is displaced from the first position to the secondposition, thereby making the catheter hub and the catheter operationmember advance without interference and achieving easy detachment fromthe needle hub.

In this case, preferably, the catheter is supported by being interposedbetween the catheter operation member and the support member in aninitial state in which the needle tip projects from a distal end of thecatheter.

Thus, because the catheter is supported by being interposed between thecatheter operation member and the support member in the initial state,the catheter and the inner needle can be prevented from being warped atthe time of puncturing the patient with the catheter and the innerneedle. Therefore, the user can perform puncturing with the catheter andthe inner needle without any discomfort.

Furthermore, preferably, the support member has the support main bodyportion inhibited from being moved from the first position in an initialstate, and the support main body portion is released from inhibition ofmovement from the first position along with advancement of the catheteroperation member relative to the needle hub.

Thus, because the support member is inhibited from being moved from thefirst position in the initial state, the catheter can be stablysupported. On the other hand, because the support main body portion isreleased from inhibition of movement at the time of advancement of thecatheter operation member, the catheter hub and the catheter operationmember can be smoothly exposed from the needle hub.

Moreover, preferably, the catheter operation member includes a holdingportion adapted to directly hold the catheter in a detachable manner.

With this structure, because the holding portion directly holds thecatheter, warping can be prevented by the catheter operation member atthe time of puncture with the catheter and the inner needle and at thetime of inserting the catheter. At this point, because the supportmember can support the catheter on the opposite side of the catheteroperation member, the catheter can be prevented from slipping out fromthe holding portion.

Additionally, preferably, the support member is rotatably attached tothe needle hub.

Thus, in the case where the support member is rotatably attached to theneedle hub, the support main body portion can be displaced in a shortdistance between the first position and the second position, and thecatheter assembly can be downsized.

Furthermore, preferably, the support member includes an axial rodportion rotatably attached to the needle hub, and the support main bodyportion projects in a direction orthogonal to an axial direction of theaxial rod portion.

With this structure, the support main body portion is rotated around theaxial rod portion attached to the needle hub and smoothly displacedbetween the first position and the second position, and it is possibleto easily switch between a catheter supportable state and a detachablestate of the catheter hub and the like.

In addition to the above-described components, preferably, the needlehub includes a groove-like rail portion, the axial rod portion includesa groove portion arranged in the rail portion, the catheter operationmember includes: a side edge housed in the rail portion and the grooveportion in a manner freely slidable and adapted to be guided at the timeof relative movement; and a cut-out portion formed by cutting out theside edge at a position same as or near an attachment position to thecatheter hub and adapted not to be housed in the rail portion and thegroove portion.

With this structure, in the case where the side edge of the catheteroperation member exists in the groove portion, the support memberbecomes unable to be rotated and the catheter supportable state can becontinued by making the support main body portion stand by at the firstposition. On the other hand, in the case where the cut-out portion ofthe catheter operation member exists in the groove portion, the supportmember becomes able to be rotated, and the catheter hub and the catheteroperation member can be allowed to pass by displacing the support mainbody portion to the second position.

Furthermore, preferably, the axial rod portion is provided with a camportion, and the groove portion extends from one end of the cam portionto the other end of the cam portion

Thus, because the groove portion is provided across the both ends of thecam portion, a non-rotatable state of the support member by the sideedge of the catheter operation member can be more surely maintained.Furthermore, when the cam portion enters the rail portion in a statethat the support main body portion is located at the second position,the side edge of the catheter operation member contacts at the time ofretraction of the catheter operation member. Consequently, the supportmain body portion can be displaced from the second position to the firstposition. This enables the support main body portion to support thecatheter again.

Moreover, preferably, the support main body portion includes aprojection adapted to contact a proximal end portion of the catheteroperation member and displace the support main body portion from thefirst position to the second position along with advancement of thecatheter operation member.

With this structure, the catheter operation member largely rotates thesupport main body portion by contacting the projection at the time ofadvancement, and the support main body portion can be surely arrangedfrom the first position to the second position. Therefore, unintendedcontact between the catheter operation member and the support member canbe prevented at the time of retracting operation of the catheteroperation member, and the catheter operation member can be made tosmoothly retract.

The support member may be a torsion spring including a coil portionformed by winding a wire member and a projecting portion formed as thesupport main body portion and projecting radially outward from the coilportion.

Thus, because the support member is formed of the torsion spring, theprojecting portion can properly support the catheter on the oppositeside of the catheter operation member. On the other hand, the projectingportion can easily allow the catheter hub and the catheter operationmember to pass by elastic deformation of the coil portion caused bycontact of the catheter operation member.

Furthermore, preferably, the support main body portion is elasticallydeformed in a direction orthogonal to a moving direction of thecatheter.

Thus, because the support main body portion is elastically deformed inthe direction orthogonal to the moving direction of the catheter, thesupport main body portion is actively warped even when, for example, theholding portion contacts the same at the time of advancing andretracting operation of the catheter operation member. Therefore,mobility of the catheter operation member can be sufficiently secured.

Additionally, preferably, the support main body portion is inclineddownward and outward in a width direction of the needle hub from aportion capable of contacting and supporting the catheter in a state ofbeing arranged at the first position.

Thus, because the support main body portion is inclined downward andoutward in the width direction of the needle hub, the catheter detachedfrom the catheter operation member can be received by an inclined uppersurface at the time of retraction of the catheter operation member.Therefore, the catheter can be prevented from being deviated in thewidth direction. Furthermore, the inclined upper surface guides thecatheter to an upper portion of the support member and makes thecatheter operation member to hold the catheter again.

According to the present invention, in the catheter assembly, thecatheter is prevented from being warped by enabling support for thecatheter at the time of inserting the catheter and furthermore thecatheter hub and the catheter operation member can be easily detachedfrom the needle hub.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view illustrating an entire structure of acatheter assembly according to a first embodiment of the presentinvention.

FIG. 2 is an exploded perspective view illustrating the catheterassembly in FIG. 1.

FIG. 3A is a first explanatory diagram illustrating operation at thetime of using the catheter assembly, and FIG. 3B is a second explanatorydiagram illustrating operation of the catheter assembly subsequent toFIG. 3A.

FIG. 4A is a third explanatory diagram illustrating operation of thecatheter assembly subsequent to FIG. 3B, and FIG. 4B is a fourthexplanatory diagram illustrating operation of the catheter assemblysubsequent to FIG. 4A.

FIG. 5 is a perspective view of an inner needle and a needle hub in FIG.2 when viewed from a lower side.

FIG. 6 is a perspective view of a catheter operation member when viewedfrom an angle different from FIG. 2.

FIG. 7A is a perspective view of a support member when viewed from alower side, and FIG. 7B is a perspective view of the support member whenviewed from an obliquely upper side.

FIG. 8 is a perspective view illustrating an enlarged supporting stateof the catheter by the catheter operation member and the support member.

FIG. 9A is a perspective view illustrating a state in which a side edgeof the catheter operation member is positioned in an operation membergroove of the support member, and FIG. 9B is a perspective viewillustrating a state in which an inclined edge of the catheter operationmember is positioned in the operation member groove portion of thesupport member.

FIG. 10A is a plan view illustrating a state in which a support mainbody portion is positioned at a first position when viewed from a lowerside, and FIG. 10B is a plan view illustrating a state in which thesupport main body portion is positioned at a second position when viewedfrom a lower side.

FIG. 11 is a perspective view illustrating an entire structure of acatheter assembly according to a first modified example.

FIG. 12A is a perspective view illustrating a state in which a supportspring portion is displaced to the second position when viewed from anobliquely lower side, and FIG. 12B is a perspective view illustrating astate in which a catheter hub, an auxiliary member hub, and a needleprotection member retract in a proximal end direction when viewed froman obliquely upper side.

FIG. 13 is a perspective view illustrating an entire structure of acatheter assembly according to a second embodiment of the presentinvention.

FIG. 14 is a perspective view illustrating a needle hub and an innerneedle of the catheter assembly in FIG. 13.

FIG. 15 is a perspective view illustrating an entire structure of acatheter assembly according to a second modified example.

FIG. 16 is a perspective view illustrating an entire structure of acatheter assembly according to a third modified example.

DETAILED DESCRIPTION

In the following description, catheter assemblies according toembodiments the present invention will be described in details withreference to the drawings by exemplifying preferable embodiments (firstand second embodiments).

In the case of performing transfusion, blood transfusion, and the liketo a patient (living body), a catheter assembly 10 according to thepresent invention is used to construct an introducing portion formedicinal solution and the like by being tapped into the patient's bodyand indwelled. The catheter assembly 10 may be used as a catheter havinga length longer than a peripheral intravenous catheter (such as acentral intravenous catheter, a PICC, and a midline intravenouscatheter). Note that the catheter assembly 10 may also be formed as aperipheral venous catheter. Furthermore, the catheter assembly 10 is notlimited to a venous catheter and may also be formed as an arterycatheter such as peripheral artery catheter.

First Embodiment

As illustrated in FIGS. 1 and 2, a catheter assembly 10 according to afirst embodiment includes a catheter 12, a catheter hub 14 to fixe andhold the catheter 12, a hollow inner needle 16 inserted into thecatheter 12, a needle hub 18 to fix and hold the inner needle 16, acatheter operation member 20 attached to an upper side of the catheterhub 14, a tube-like auxiliary member 22 inserted between the catheter 12and the inner needle 16, an auxiliary member hub 24 to fix and hold theauxiliary member 22, and a needle protection member 26 connected to thecatheter hub 14 and a proximal end of the auxiliary member hub 24.

In an initial state before use, the catheter assembly 10 has a multipletube structure (multiple tube unit 11) in which the catheter 12,auxiliary member 22, and inner needle 16 are stacked sequentially fromthe outside. The catheter operation member 20 has a structure todirectly hold the multiple tube unit 11. Additionally, in the initialstate, the catheter assembly 10 houses, inside the needle hub 18, partof the multiple tube unit 11, catheter hub 14, catheter operation member20, auxiliary member hub 24, and needle protection member 26 by suitablyassembling these components.

A user such as a doctor or a nurse grips the needle hub 18 of thecatheter assembly 10 in the initial state illustrated in FIG. 1 andpunctures a blood vessel (venous or artery) of the patient with a distalend of the multiple tube unit 11. The user performs advancing operationof the catheter operation member 20 relative to the needle hub 18 whilekeeping the puncturing state, thereby making the catheter 12 advancemore to a distal end side (deeper inside the blood vessel) than theinner needle 16.

The catheter assembly 10 also integrally moves the catheter hub 14connected to the catheter operation member 20, auxiliary member hub 24,and needle protection member 26 as illustrated in FIG. 3A along withadvancement of the catheter 12 or retraction of the needle hub 18relative to the catheter 12. At this point, because the inner needle 16is fixed to the needle hub 18, the multiple tube unit 11 is changed tohave a double-stack structure of the catheter 12 and the auxiliarymember 22. Furthermore, the catheter operation member 20 releases themultiple tube unit 11 from being held at the time of performingadvancing operation of the catheter 12.

In the case of continuing advancement, a portion up to the needleprotection member 26 slips out from the distal end of the needle hub 18,and a needle tip 16 a of the inner needle 16 is housed inside the needleprotection member 26 as illustrated in FIG. 3B. Then, as illustrated inFIG. 4A, the catheter 12 and the catheter hub 14 can be separated fromthe auxiliary member hub 24 and the needle protection member 26 whichhave slipped out from the needle hub 18, and are detached from theauxiliary member 22 along with continuous advancement. Finally, thecatheter operation member 20 is detached from the catheter hub 14 asillustrated in FIG. 4B, thereby indwelling the catheter 12 and thecatheter hub 14 in the patient. In the following, a structure of thecatheter assembly 10 will be specifically described.

As illustrated in FIG. 2, the catheter 12 of the catheter assembly 10has flexibility, and a cavity 13 is formed inside in a penetratingmanner. The cavity 13 is formed to have a diameter capable of housingthe inner needle 16 and the auxiliary member 22 and flowing medicinalsolution, blood, and the like. A length of the catheter 12 is notparticularly limited and can be suitably designed in accordance withusage, conditions, and the like, and for example, the length is set toabout 14 to 500 mm, set to about 30 to 400 mm, or set to about 76 to 200mm.

A constituent material of the catheter 12 is not limited but a softresin material may be suitable, and for example, fluororesins such aspolytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer(ETFE), perfluoroalkoxy fluororesin (PFA), olefin resins such aspolyethylene and polypropylene, or mixtures thereof, polyurethane,polyesters, polyamides, polyether nylon resins, and mixtures of theolefin resin and ethylene/vinyl acetate copolymer, and the like may beexemplified.

A proximal end of the catheter 12 is fixed to a distal end of thecatheter hub 14 by a suitable fixing method (caulking, fusion, bonding,and the like). The catheter hub 14 is exposed on patient's skin with thecatheter 12 being inserted into a blood vessel, and indwelled togetherwith the catheter 12 by being pasted with a tape or the like.

The catheter hub 14 is formed in a cylindrical shape tapered in a distalend direction. A constituent material of the catheter hub 14 is notparticularly limited, but for example, thermoplastic resins such aspolypropylene, polycarbonate, polyamides, polysulfone, polyarylate, andmethacrylate-butylene-styrene copolymer may be applied. A transfusiontube connector not illustrated is connected to a proximal end side ofthe catheter hub 14 after detachment of the inner needle 16.

A hollow portion 15 that is in communication with the cavity 13 of thecatheter 12 and allows transfusion solution to flow is provided insidethe catheter hub 14. The hollow portion 15 may house a hemostasis valve,a plug, and the like not illustrated adapted to prevent back-flow ofblood at the time of puncture with the inner needle 16 and also enabletransfusion along with insertion of the transfusion tube connector.

Furthermore, an annular projection 28 which projects radially outwardand revolves in a circumferential direction of the catheter hub 14 isformed close to a distal end of an outer peripheral surface of thecatheter hub 14. Additionally, same as the annular projection 28, ascrew portion 30 that revolves in the circumferential direction of thecatheter hub 14 is formed in a projecting manner at a proximal end ofthe outer peripheral surface of the catheter hub 14.

On the other hand, the inner needle 16 of the catheter assembly 10 isformed as a hollow tube having rigidity capable of puncturing skin of aliving body, and arranged in the cavity 13 of the catheter 12 and thehollow portion 15 of the catheter hub 14 in a penetrating manner. Theinner needle 16 has an entire length longer than the catheter 12 and isformed to have a diameter gradually becoming larger in the distal enddirection from the proximal end portion, and the distal end thereof isprovided with a sharp needle tip 16 a. In the initial state illustratedin FIG. 1, the multiple tube unit 11 exposes the needle tip 16 a fromthe catheter 12 and the auxiliary member 22. A through-hole 16 b isprovided inside the inner needle 16 in an axial direction of the innerneedle 16. Meanwhile, a groove portion (not illustrated) may also beprovided in the axial direction on an outer peripheral surface of theinner needle 16. Additionally, the inner needle 16 may also be a solidneedle.

As a constituent material of the inner needle 16, for example, metallicmaterials such as stainless steel, aluminum or an aluminum alloy, ortitanium or a titanium alloy, a hard resin, ceramics, and the like maybe exemplified. The inner needle 16 is firmly fixed to the needle hub 18by a suitable fixing method (fusion, bonding, insert molding, and thelike).

As illustrated in FIG. 5, the needle hub 18 is formed as a housing 19including a lower wall 32, a pair of side walls 34 a, 34 b projectingupward from a side portions 32 a of the lower wall 32. The housing 19has an elongated cup-like shape extending shorter than an axial lengthof the inner needle 16. A housing space 40 to house part of the multipletube unit 11, the catheter hub 14, auxiliary member hub 24, and needleprotection member 26 is formed on an inner side surrounded by the lowerwall 32 and the pair of side walls 34 a, 34 b.

A constituent material to form the needle hub 18 is not particularlylimited and, for example, may be suitably selected from materialsexemplified for the catheter hub 14. Meanwhile, the catheter hub 14 andthe needle protection member 26 are exposed on the upper side in orderto enable the catheter assembly 10 to rotate the catheter 12 relative tothe inner needle 16. Alternatively, the catheter assembly 10 may alsohave a structure in which the catheter hub 14, needle protection member26, and the like are covered by forming an upper wall or attaching a lidbody to the housing 19.

The lower wall 32 includes: a pair of the side portions 32 a formedflat; and a guide groove portion 32 b interposed between the pair of theside portions 32 a and recessed downward in an arc shape. In the guidegroove portion 32 b, the catheter hub 14, auxiliary member hub 24, andneedle protection member 26 are slidably arranged in a longitudinaldirection of the housing 19. On a proximal end side and in a centerportion in a width direction of the lower wall 32 (guide groove portion32 b), a needle holding portion 36 projecting upward from an uppersurface thereof and adapted to fix the proximal end portion of the innerneedle 16 at a predetermined height is integrally formed. Meanwhile, theneedle holding portion 36 may also be formed separately from the housing19 and may be bonded and fixed to the housing 19.

The pair of side walls 34 a, 34 b extends in parallel in a longitudinaldirection together with the lower wall 32 and has a constant verticalwidth on the proximal end side and an intermediate side, and thevertical width on the distal end side is formed wider relative to theintermediate side. Groove-like rail portions 42 are provided on upperportions on the distal end sides of the respective side walls 34 a, 34b. The pair of rail portions 42 linearly extends in the longitudinaldirection on inner surfaces of the wide portions of the respective sidewalls 34 a, 34 b, and reaches upper surfaces on the intermediate sides.The respective rail portions 42 house side edges 46 a, 46 b of thecatheter operation member 20, and guide advancement and retraction ofthe catheter operation member 20. A distal end of a groove wallconstituting the rail portion 42 is formed to have a curved surface 42 ato allow the catheter operation member 20 to be curved.

Furthermore, an arrangement recessed portion 43 to attach a supportmember 44 is provided on the side wall 34 a. The arrangement recessedportion 43 is cut out in the proximal end direction from the distal endof the side wall 34 a, and located between the lower wall 32 and therail portion 42. The lower wall 32 and the side wall 34 a at a formingposition of the arrangement recessed portion 43 are provided with a pairof bearing holes 43 a, 43 b to rotatably attach the support member 44. Awindow 43 c in which a cam projecting portion 106 (refer to FIG. 7A) ofthe support member 44 described later is housed is provided at aposition overlapping with the rail portion 42 (between the upper bearinghole 43 a and the arrangement recessed portion 43), and an cavity to bearranged with an axial rod portion 100 is formed on a wall between thearrangement recessed portion 43 and the window 43 c. Furthermore, alocking recessed portion 43 d into which a locking projecting portion118 is inserted is formed on the lower wall 32 when the support mainbody portion 102 of the support member 44 is rotated about 90 degrees.

Referring back to FIG. 2, the auxiliary member 22 of the catheterassembly 10 supports the catheter 12 from the inside and has a functionto assist insertion of the catheter 12 into a blood vessel. Theauxiliary member 22 has an outer diameter smaller than an inner diameterof the catheter 12, and is formed inside a hollow tube having an innerdiameter larger than an outer diameter of the inner needle 16. Aproximal end portion of the auxiliary member 22 is fixed to and held bythe auxiliary member hub 24 by a suitable fixing method (caulking,fusion, bonding, and the like).

The auxiliary member hub 24 has a distal end side thereof assembled tothe catheter hub 14 in a freely detachable manner, and the needleprotection member 26 is assembled to a proximal end side thereof in afreely detachable manner. The auxiliary member hub 24 connects thecatheter hub 14 and the needle protection member 26 respectively in amanner integrally rotatable. Meanwhile, the auxiliary member hub 24 mayalso integrated to the needle protection member 26 (more specifically,the auxiliary member 22 may also be fixed to the needle protectionmember 26). Furthermore, the catheter assembly 10 may not necessarilyinclude the auxiliary member 22 and the auxiliary member hub 24. In thiscase, the needle protection member 26 is directly attached to theproximal end of the catheter hub 14.

In the initial state, the needle protection member 26 has the innerneedle 16 arranged in a penetrating manner. Furthermore, the needle tip16 a having moved due to detachment of the catheter 12 and the innerneedle 16 is housed, and the needle tip 16 a is prevented from beingexposed again. The needle protection member 26 houses a shutter 82 and aslip-out stop member 94 in order to prevent the needle tip 16 a frombeing exposed again. The shutter 82 is elastically deformed bycontacting the outer peripheral surface of the inner needle 16 in astate that the inner needle 16 is arranged in a penetrating manner, andwhen the needle tip 16 a slips out, the shutter 82 is elasticallyrestored and shuts a penetrating route of the inner needle 16. Theslip-out stop member 94 includes a hole having a diameter smaller thanthat of the needle tip 16 a of the inner needle 16, thereby inhibitingthe needle tip 16 a from slipping out in the proximal end direction.

The catheter operation member 20 directly holds the catheter 12 and alsois attached to the catheter hub 14, thereby making the catheter 12 andthe catheter hub 14 advance and retract relative to the inner needle 16and the housing 19. As illustrated in FIGS. 2 and 6, the catheteroperation member 20 includes an operation plate portion 46 (longportion) extending in the longitudinal direction of the housing 19, anda hub attachment portion 48 integrally formed with a proximal end of theoperation plate portion 46 and attached to the catheter hub 14 freelydetachably manner.

The operation plate portion 46 is a portion where a user's finger istouched and advancing and retracting operation is performed. In theinitial state, a pair of side edges 46 a, 46 b of the operation plateportion 46 is arranged at the pair of rail portions 42 and uppersurfaces of the pair of side walls 34 a, 34 b on the proximal end sidesof the rail portions 42. The operation plate portion 46 is formed thinenough to have flexibility capable of being curved in a directionorthogonal to a surface direction of the operation plate portion 46,more specifically, in a direction separating away from the inner needle16. A constituent material of the operation plate portion 46 (catheteroperation member 20) is not particularly limited and, for example, maybe suitably selected from the materials exemplified for the catheter hub14.

As illustrated in FIG. 1, the operation plate portion 46 is formed asubstantially rectangular shape in a plan view, and a cut-out portion 47is provided on a proximal end side of a side edge 46 a (setting placeside of the support member 44). The cut-out portion 47 forms a leveldifference 47 a at a boundary between a forming position thereof and theoperation plate portion 46 by cutting off the operation plate portion 46toward the inside in a width direction. Furthermore, an inclined edge 46c gradually inclined toward the inside in the width direction in theproximal end direction is formed at the side edge 46 a located more onthe distal end side than the level difference 47 a.

Additionally, as illustrated in FIGS. 2 and 6, an upper side rib 50 andtabs 52, 54 are provided on an upper surface of the operation plateportion 46, a distal end camber portion 56 is provided at a distal endof the operation plate portion 46, and a holding portion 58 and a lowerside rib 51 are provided on a lower surface of the operation plateportion 46.

A plurality of upper side ribs 50 and a plurality of lower side ribs 51are provided in a longitudinal direction of the operation plate portion46. These upper and lower side ribs 50, 51 project upward and downwardrespectively and linearly extend in a width direction of the operationplate portion 46, thereby enhancing strength in the width direction ofthe operation plate portion 46. With this structure, the operation plateportion 46 is prevented from being bent, warped, or the like inside thehousing 19 even when external force is applied from the outside, andadvancing and retracting is smoothly performed along the upper surfacesof the pair of side walls 34 a, 34 b and the rail portions 42.

The tabs 52, 54 are portions provided assuming that the user's fingerdirectly touches the same, and the tabs project higher than the upperside rib 50. The number of tabs 52, 54 to be provided is not limited totwo illustrated in FIG. 2, and one tab or three or more tabs may beprovided.

As illustrated in FIG. 6, the distal end camber portion 56 includes athick portion 56 a projecting to the lower surface side of the operationplate portion 46, and becomes gradually thinner from the thick portion56 a in the distal end direction while being curved upward. An insertiongroove 57 through which the catheter 12 is made to pass in anon-contacting manner or with little friction is formed at a centerportion in a width direction of the thick portion 56 a. With advancementof the catheter operation member 20, a cambered lower surface side ofthe distal end camber portion 56 contacts the patient or is gripped bythe user, thereby guiding the operation plate portion 46 to be directedobliquely upward.

On the other hand, a plurality of holding portions 58 of the catheteroperation member 20 is provided in the longitudinal direction of theoperation plate portion 46 (five holding portions in FIG. 6). Theholding portions 58 are arranged at equal intervals in the longitudinaldirection of the operation plate portion 46, and hold the catheter 12 atthe respective places by contacting the outer peripheral surfacethereof. Meanwhile, the catheter operation member 20 may also have astructure in which one holding portion 58 is provided at onepredetermined place to hold the catheter 12.

The plurality of holding portions 58 each includes a pair of projectingpieces 70 (projecting portions) projecting downward from the lowersurface of the operation plate portion 46. The pair of projecting pieces70 is symmetrically formed each other interposing an intermediateportion in the width direction of the operation plate portion 46 (in thefollowing, a projecting piece 70 located on a near side in FIG. 6 willbe also referred to as a first projecting piece 71 and a projectingpiece 70 located on a far side in FIG. 6 will be also referred to as asecond projecting piece 72).

The first and second projecting pieces 71, 72 are formed in arectangular shape that is wide in the width direction of the operationplate portion 46. An interval of respective inner edges of the firstprojecting piece 71 and the second projecting piece 72 is set slightlywider than the outer diameter of the catheter 12. Nail portions 73, 74slightly projecting to an inner side in the width direction are formedon lower portion sides of the respective inner edges. An interval ofrespective projecting ends of the pair of the nail portions 73, 74 isset slightly narrower than the outer diameter of the catheter 12 bycoming close to each other.

When the catheter 12 is assembled to the catheter operation member 20,the catheter 12 passes the pair of nail portion 73, 74 and is easilynipped between the first and second projecting pieces 71, 72. Meanwhile,“nipped” in the present specification means a state that the holdingportions 58 contact and hold the catheter 12 with weak engagement force.Needless to mention, the structure of the holding portion 58 is notlimited to the above-described pair of the projecting pieces 70, andvarious kinds of structures to hold the catheter 12 are applicable.

The first and second projecting pieces 71, 72 are formed in a squareshape having round corners at protruding ends (lower ends) in sidesectional view. The round corners of the first and second projectingpieces 71, 72 allow the support member 44 located on the lower side toeasily climb over the first and second projecting pieces 71, 72(improves slidability) when the catheter operation member 20 advancesand retracts.

Moreover, the first and second projecting pieces 71, 72 are formed in aprojecting manner such that phases (forming positions) are mutuallydeviated in the longitudinal direction of the operation plate portion46. In other words, the first projecting piece 71 and the secondprojecting piece 72 hold the catheter 12 with weak engagement force bynot clamping the catheter 12 on the same axis. Therefore, when theoperation plate portion 46 is curved, the catheter operation member 20displaces and detaches hooked portions of the catheter 12 in the orderof the first projecting piece 71 and the second projecting piece 72.

On the other hand, the hub attachment portion 48 of the catheteroperation member 20 is formed in a box shape by a pair of side plates 60projecting downward from the operation plate portion 46 and asemi-cylindrical upper plate 62 slightly projecting upward from theoperation plate portion 46. In the case of viewing the hub attachmentportion 48 from the lower direction, a proximal end side and anintermediate side of the pair of the side plates 60 extend in paralleland a distal end side continuous to the intermediate side is inclinedinward in the distal end direction.

The catheter hub 14 is rotatably housed inside the pair of side plates60 and the upper plate 62 while an attachment chamber 64 to inhibitaxial movement of the catheter hub 14 relative to the hub attachmentportion 48 is provided. The attachment chamber 64 is open to the outsideat the lower portion and the proximal end of the hub attachment portion48.

An inner surface of the attachment chamber 64 is formed with: a lockinggroove 66 formed by overlaying a trapezoid hole on a round hole; agroove portion 68 adapted to arrange the pair of side plates 60 and theupper plate 62 extending in a U-shape; and a pair of projections 69projecting inside the hub attachment portion 48. The locking groove 66allows the catheter 12 to pass through the trapezoid hole having a widelower side and a narrow upper side and then be arranged in the roundhole, and appropriately locks the catheter 12 by hooking the catheter ata boundary portion between the trapezoid hole and the round hole. Thegroove portion 68 rotatably houses the annular projection 28 of thecatheter hub 14 in a manner inhibiting movement thereof in the distalend and proximal end directions. Furthermore, the pair of projections 69hooks the outer peripheral surface on the proximal end side of thecatheter hub 14 with light engagement force.

Furthermore, as illustrated in FIG. 2, because the catheter assembly 10supports the lower side of the catheter 12 held by the catheteroperation member 20, the support member 44 is provided at the distal endside of the housing 19. The support member 44 includes the cylindricalaxial rod portion 100 and the support main body portion 102 projectingin a lateral direction from the axial rod portion 100 (directionorthogonal to an axial center of the axial rod portion 100).

As illustrated in FIGS. 2, 7A and 7B, the axial rod portion 100 extendsshort in upper and lower directions, and an upper end portion and alower end portion are inserted in to the pair of upper and lower bearingholes 43 a, 43 b of the arrangement recessed portion 43 respectively.The support member 44 is assembled to the housing 19 in a mannerrotatable around the axial rod portion 100 as a base point.

A connection reinforcing portion 104 corresponding to a vertical lengthof the arrangement recessed portion 43 is formed in a bulging manner onthe lower side of the axial rod portion 100 in a state that the supportmember 44 is assembled to the housing 19. The support main body portion102 is connected to the connection reinforcing portion 104. Furthermore,a pair of the cam projecting portions 106 (cam portions) functioning asa cam portion adapted to rotatably operate the support member 44 isintegrally formed on an upper side of the axial rod portion 100. Thepair of cam projecting portions 106 is provided at a predeterminedposition (position housed in the window 43 c in a state of beingassembled to the housing 19), and projects mutually in oppositedirections to the same extent, interposing the axial rod portion 100.

Furthermore, the support member 44 includes an operation member grooveportion 108 at a position facing the axial rod portion 100 and thesupport main body portion 102 of the pair of cam projecting portions106. The operation member groove portion 108 linearly extends from amost distal end of the cam projecting portion 106 on the distal end sideto a most proximal end of the cam projecting portion 106 on the proximalend side in the initial state. The operation member groove portion 108is arranged at a position corresponding to the rail portion 42, andhouses the side edge 46 a of the catheter operation member 20 in aslidable manner together with the rail portion 42.

On the other hand, the support main body portion 102 of the supportmember 44 is a portion to be moved by rotation around the axial rodportion 100 as the rotation point in a state of being assembled to thehousing 19. More specifically, the support main body portion 102 isdisplaced to a first position P1 located inside the housing space 40 andcapable of contacting and supporting the catheter 12 (refer to FIGS. 7Band 10A) and a second position P2 located outside the housing 19 and inthe arrangement recessed portion 43 different from the first positionP1, and not contacting the catheter 12 (refer to FIG. 10B). An anglebetween the first position P1 and the second position P2 around theaxial center of the axial rod portion 100 is preferably 90 degrees ormore such that the catheter hub 14, auxiliary member hub 24, and needleprotection member 26 can easily slip out. According to the presentembodiment, the angle is set to 90 degrees such that the cam projectingportion 106 is located inside the rail portion 42 at the second positionP2.

The support main body portion 102 is formed in an S shape having a sizealmost same as the vertical width of the arrangement recessed portion 43in a front view, and has spring force capable of being elasticallydeformed in the vertical direction. A raised portion 110 slightly risingupward is formed on an upper surface of the support main body portion102. The raised portion 110 is the first position P1 of the support mainbody portion 102 and can contact the catheter 12(multiple tube unit 11)held by the catheter operation member 20. Meanwhile, in the presentembodiment, the support main body portion 102 faces the catheter 12 in anon-contacting manner in a state of being located in the first positionP1, and is adapted to contact and support the same when pressed by theuser. However, not limited thereto, the support main body portion 102may be adapted to contact and support the catheter 12 when located inthe first position P1.

Furthermore, a distal end inclined surface 112 inclined downward and inthe distal end direction is formed on an upper distal end side of thesupport main body portion 102, and a proximal end inclined surface 114inclined downward and in the proximal end direction is formed on anupper proximal end side of the support main body portion 102.Additionally, a wing 116 projecting and inclined downward and outward ina width direction separating from the axial rod portion 100 isintegrally formed at an end portion continued to the raised portion 110of the support main body portion 102.

The locking projecting portion 118 is formed downward in a projectingmanner on a lower surface of the support main body portion 102. Thelocking projecting portion 118 is inserted into the locking recessedportion 43 d of the housing 19 at the second position P2 of the supportmain body portion 102. Furthermore, a contacting projection 120projecting the proximal end direction is provided at a proximal end on alower portion side of the support main body portion 102. The contactingprojection 120 contacts the side plates 60 (hub attachment portion 48)at the time of advancement of the catheter operation member 20, andinduces the support main body portion 102 to be displaced to the secondposition P2 distant from the first position P1 by 90 degrees.

A constituent material of the support member 44 is not particularlylimited and, for example, may be suitably selected from the materialsexemplified for the catheter hub 14. Meanwhile, the support member 44may be provided not only as a separate body from the housing 19 but alsoformed integrally with the housing 19. Furthermore, the support member44 may not only provided at the side wall 34 a of the housing 19 butalso provided at the side wall 34 b, and a pair thereof may be providedat both of the side walls 34 a, 34 b. Additionally, a rotationaldirection of the support main body portion 102 is not limited to theplane direction of the housing 19 but in a side surface directionincluding upward and downward.

The catheter assembly 10 according to the present embodiment has thebasic structure as described above, and functions and effects thereofwill be described below.

As described above, the catheter assembly 10 is used to construct anintroducing portion for transfusion to a patient. In the initial stateillustrated in FIG. 1, the catheter hub 14, auxiliary member hub 24, andneedle protection member 26 are connected, and the catheter hub 14 ishoused in the attachment chamber 64 of the catheter operation member 20(hub attachment portion 48) and integrally housed in the housing space40 of the housing 19.

Furthermore, in the initial state, the support main body portion 102 ofthe support member 44 assembled to the distal end portion of the housing19 stands by at the first position P1, and faces the multiple tube unit11 held by the plurality of holding portions 58 of the catheteroperation member 20 as illustrated in FIG. 8. Each of the holdingportions 58 nips the outer peripheral surface of the catheter 12 withweak engagement force in each place in the axial direction, and thecatheter 12 is firmly held as the entire catheter operation member 20.

At the time of using the catheter assembly 10, the user grips andoperates the housing 19, and punctures a patient with the multiple tubeunit 11. At the time of puncture, the holding portions 58 hold thecatheter 12, thereby preventing the multiple tube unit 11 from beingwarped inside the housing 19 even when resistance force is receivedalong with puncture. Furthermore, when the distal end side of thecatheter operation member 20 is pressed downward by the user's finger atthe time of puncture, the multiple tube unit 11 is contacted andsupported by the support member 44 standing by at the first position P1.Therefore, the multiple tube unit 11 is more prevented from being warpedby being fixed between the catheter operation member 20 (insertiongroove 57 of the distal end camber portion 56) and the support member 44(raised portion 110).

As a result, the extending state of the multiple tube unit 11 from thedistal end of the housing 19 is properly maintained, and the user canpuncture the patient with the multiple tube unit 11 without anydiscomfort. Furthermore, the catheter assembly 10 can be formed thinnerby reducing strength of the inner needle 16, and burden on the patientcan be reduced.

As illustrated in FIG. 3A, in a puncture state with the multiple tubeunit 11, the user makes the catheter 12 advance relative to the innerneedle 16 and inserts the same into a blood vessel. At this point, theuser puts a finger on the upper side rib 50 or the tabs 52, 54 of thecatheter operation member 20 and makes the catheter operation member 20advance in the distal end direction relative to the housing 19 (relativemovement). In advancing operation of the catheter operation member 20,the multiple tube unit 11 is kept being held by the holding portions 58,and the catheter 12 smoothly advances.

At the time of advancing operation, because the side edge 46 a of theoperation plate portion 46 exists in the operation member groove portion108 of the support member 44 as illustrated in FIG. 9A, the supportmember 44 is prevented from being rotated, and the support main bodyportion 102 continues standing by at the first position P1. Therefore,the support member 44 keeps the state capable of supporting the lowerside of the multiple tube unit 11, and the multiple tube unit 11 isprevented from slipping out from the holding portions 58 even in thecase where the catheter 12 receives reaction force from the skin and thelike at the time of inserting the catheter 12. Therefore, for example,the needle tip 16 a of the inner needle 16 is prevented from retractingand slipping out from the skin by being warped, and inconvenience suchas puncturing the skin again with the inner needle 16 can be avoided.

Furthermore, because the support main body portion 102 has elastic forcein the vertical direction and includes the proximal end inclined surface114, the support main body portion 102 is suitably and elasticallydeformed to allow the holding portion 58 to pass when contacted by theholding portion 58 (pair of projecting pieces 70) at the time ofadvancement. Consequently, the catheter operation member 20 makes thecatheter 12 smoothly advance.

When the distal end camber portion 56 contacts the patient's skin alongwith advancement in the distal end direction or when the user grips thedistal end camber portion 56 or the like, the operation plate portion 46of the catheter operation member 20 is curved in a manner separatingaway from the axial direction of the multiple tube unit 11. Theoperation plate portion 46 is curved from the distal end side of theoperation plate portion 46, and the holding portions 58 aligned in thelongitudinal direction sequentially detach the multiple tube unit 11from the distal end side against respective engagement force. Even inthe case where holding by the holding portion 58 on the distal end sideis released due to curving of the operation plate portion 46, theholding portion 58 on the proximal end side where linearity is keptinside the housing 19 can continue holding the multiple tube unit 11.Furthermore, the support main body portion 102 of the support member 44keeps standing by at the first position P1 and continues supporting themultiple tube unit 11 together with the holding portions 58 holding thecatheter 12 on the proximal end side.

Here, in the case where the user cannot insert the catheter 12 smoothly,the user can once perform retracting operation of the catheter operationmember 20 and may make the catheter 12 retract relative to the innerneedle 16 and the housing 19. At the time of retraction, the operationplate portion 46 is housed again in the rail portions 42 of the housing19 and the curved state is changed to the linear state (non-curvedstate). Furthermore, due to retraction of the catheter operation member20, the wing 116 and the raised portion 110 lift the catheter 12 towardthe holding portions 58, and make the plurality of holding portions 58(pair of projecting pieces 70) nip the catheter 12 again.

When the catheter operation member 20 advances to some extent, a statein which the side edge 46 a illustrated in FIG. 9A is located in theoperation member groove portion 108 is shifted to a state in which theinclined edge 46 c of the operation plate portion 46 illustrated in FIG.9B is located in the operation member groove portion 108. At the sametime, the side plates 60 of the hub attachment portion 48 contact thecontacting projection 120 of the support main body portion 102, therebystarting rotation of the support main body portion 102 from the firstposition P1.

When the level difference 47 a of the operation plate portion 46 passesthe cam projecting portion 106 on the distal end side of the supportmember 44, the cam projecting portion 106 comes to be located at thecut-out portion 47 and the support member 44 becomes rotatable. Thecontacting projection 120 of the support main body portion 102 rotatesthe support main body portion 102 with the sufficient rotation angle (90degrees) by contact of the catheter operation member 20. As a result,the support main body portion 102 is displaced from the first positionP1 illustrated in FIG. 10A to the second position P2 illustrated in FIG.10B, and largely open a distal end side of the housing space 40.Consequently, the catheter hub 14, auxiliary member hub 24, and needleprotection member 26 can pass in the distal end direction and can easilyslip out from the housing 19.

In the state that the support main body portion 102 is located at thesecond position P2, the locking projecting portion 118 is inserted intothe locking recessed portion 43 d, thereby making the support main bodyportion 102 stand by at the second position P2. Further, in this state,one of the cam projecting portions 106 is located inside the railportion 42. Therefore, when the user perform retracting operation of thecatheter operation member 20, the support member 44 is rotated bycontact of the level difference 47 a and the cam projecting portion 106,and the support main body portion 102 is returned to the first positionP1 from the second position P2 again. When the support main body portion102 is rotated, the wing 116 extends obliquely downward. Therefore, thecatheter 12 is guided to an upper portion of the support main bodyportion 102 while the catheter 12 is prevented from being deviated inthe lateral direction. Therefore, the support member 44 can make theholding portions 58 nip the catheter 12 again along with retraction ofthe catheter operation member 20.

With advancement of the catheter operation member 20 (or with retractionof the inner needle 16 and the housing 19), the catheter hub 14 attachedto the hub attachment portion 48 and the needle protection member 26attached to the catheter hub 14 also advance. Furthermore, when thecatheter hub 14 and the needle protection member 26 slip out from thehousing 19 and advance to some extent, the needle tip 16 a of the innerneedle 16 is housed inside the needle protection member 26. The needleprotection member 26 inhibits the needle tip 16 a from slipping out bythe slip-out stop member 94, and also prevents the needle tip 16 a frombeing exposed again by opening, in front of the needle tip 16 a, theshutter 82 that has been closed by the outer peripheral surface of theinner needle 16 inside the needle protection member 26.

Furthermore, after the catheter hub 14 is detached from the housing 19,engagement between the locking groove 66, pair of projections 69 of thehub attachment portion 48, and catheter hub 14 can be easily released.Therefore, the user separates the catheter operation member 20 from thecatheter 12 and the catheter hub 14 at suitable timing, and the catheter12 and the catheter hub 14 are properly indwelled in the patient.

As described above, the catheter assembly 10 according to the presentembodiment can support the catheter 12 with the support member 44located at the first position P1 on an opposite side of the catheteroperation member 20. Therefore, at the time of advancing operation ofthe catheter operation member 20, the support member 44 contacts andsupports the catheter 12 inside the housing 19 and can prevent the samefrom being warped even in the case where the catheter 12 receivesreaction force from a patient. Consequently, the extending state of themultiple tube unit 11 is properly maintained, and the user can smoothlyinsert the catheter 12 into the patient. Furthermore, the support member44 is displaced from the first position P1 to the second position P2,thereby making the catheter hub 14 and the catheter operation member 20advance without interference and enabling easy detachment from the innerneedle 16 and the housing 19.

In the catheter assembly 10, the catheter 12 is supported by beinginterposed between the catheter operation member 20 and the supportmember 44 in the initial state. Consequently, the multiple tube unit 11can be prevented from being warped at the time of puncturing the patientwith the multiple tube unit 11. Therefore, the user can perform puncturewith the multiple tube unit 11 without any discomfort. Furthermore,because the support main body portion 102 is inhibited from being movedfrom the first position P1 in the initial state, the catheter 12 can bestably supported. On the other hand, because the support main bodyportion 102 is released from inhibition of movement at the time ofadvancement of the catheter operation member 20, the catheter hub 14 andthe catheter operation member 20 can be smoothly exposed from thehousing 19. Furthermore, because the holding portions 58 directly holdthe catheter 12, warping can be prevented by the catheter operationmember 20 at the time of puncture with the multiple tube unit 11 and thecatheter 12 and at the time of inserting the catheter 12. At this point,because the support member 44 can support the catheter 12 on theopposite side of the catheter operation member 20, the catheter 12 canbe prevented from slipping out from the holding portion 58.

In this case, when the support member 44 is rotatably attached to thehousing 19, the support main body portion 102 can be displaced in ashort distance between the first position P1 and the second position P2,and the catheter assembly 10 can be downsized. Furthermore, because thesupport main body portion 102 is provided in a manner rotatable to thehousing 19 by the axial rod portion 100, the support main body portionis smoothly displaced between the first position P1 and the secondposition P2. This enables easy switch between the supportable state forthe catheter 12 and the detachable state for the catheter hub 14 and thelike. Additionally, in the case where the side edge 46 a of the catheteroperation member 20 exists in the operation member groove portion 108,the support member 44 becomes unable to be rotated, and it is possibleto continue making the support main body portion 102 stand by at thefirst position P1 capable of supporting the catheter 12. On the otherhand, in the case where the cut-out portion 47 of the catheter operationmember 20 exists in the operation member groove portion 108, the supportmember 44 becomes rotatable and the support main body portion 102 can bedisplaced to the second position P2 at which the catheter hub 14 and thelike are allowed to pass.

Furthermore, at the time of advancing and retracting operation of thecatheter operation member 20, the support main body portion 102 iselastically deformed and allows the holding portion 58 to pass even whenthe holding portion 58 holding the catheter 12 contact the same.Therefore, mobility of the catheter operation member 20 can besufficiently secured. The catheter operation member 20 largely rotatesthe support main body portion 102 by contacting the contactingprojection 120 at the time of advancement, and the support main bodyportion 102 can be surely arranged at the second position P2 from thefirst position P1. Therefore, unintended contact between the catheteroperation member 20 and the support member 44 can be prevented at thetime of retracting operation of the catheter operation member 20, andthe catheter operation member 20 can be made to smoothly retract.

Note that the catheter assembly 10 according to the present invention isnot limited to the above-described embodiment, and various kinds ofapplication examples and modified examples are applicable. For example,the catheter assembly 10 may have a structure in which a guide wire notillustrated is housed in the through-hole 16 b of the inner needle 16,and the guide wire is exposed from the needle tip 16 a to guide thecatheter 12 by controlling a guide wire operation member not illustratedand connected to the guide wire.

Furthermore, the support member 44 capable of supporting the catheter 12inside the housing 19 is not limited to the above-described component,and for example, a slider (not illustrated) that slides between thefirst position P1 and the second position P2 may be applied instead ofthe support member 44. In this case, the slider is adapted to advanceand retract in a width direction of the housing 19 (direction orthogonalto the moving direction of the catheter 12). With this structure, theslider can easily switch the position between the first position P1capable of supporting the catheter 12 near the axial center of thehousing 19 and the second position P2 at which the catheter hub 14 andthe like are allowed to pass outside the housing 19.

FIRST MODIFIED EXAMPLE

Next, a catheter assembly 10A according to a first modified example willbe described. Note that a reference sign same as the one used in theabove-described embodiment has the same structure or the same functionin the following description, and a detailed description therefor willbe omitted.

A catheter assembly 10A according to the first modified example differsfrom the catheter assembly 10 in that a torsion spring 130 is adopted asthe support member to support the catheter 12 as illustrated in FIG. 11.Furthermore, a needle hub 18A (housing 19A) of the catheter assembly 10Aincludes a housing portion 132 to arrange the torsion spring 130 insteadof the above-described arrangement recessed portion 43.

The housing portion 132 slightly bulges outward in the width directionfrom the side wall 34 a of the housing 19A and includes a spring housingchamber inside thereof (not illustrated). Furthermore, the housingportion 132 includes, on the lower side of the rail portion 42, a slit132 a capable of passing a support spring portion 136 when the supportspring portion 136 of the later-described torsion spring 130 isdisplaced.

The torsion spring 130 includes: a coil portion 134 formed by winding awire member made of a metallic material in a spiral form; and thesupport spring portion 136 (support main body portion, projectingportion) projecting from an upper end of the coil portion 134 in alateral direction (direction orthogonal to an axial center of the coilportion 134). The coil portion 134 is assembled to the housing 19A suchthat the axial direction thereof is formed along a vertical direction ofthe housing 19A. Furthermore, the coil portion 134 includes a pin 134 aprojecting from a lower end portion, and the pin 134 a is fixed to thehousing portion 132 in a non-rotatable manner.

The support spring portion 136 is formed in a U-shape in a plane view,and extends from the coil portion 134 to a position exceeding themultiple tube unit 11 and the holding portion 58 (first position P1) inthe state that the torsion spring 130 is assembled to the housing 19A.With this structure, the support spring portion 136 can support themultiple tube unit 11 and prevents the multiple tube unit 11 from beingwarped when the user operates a catheter operation member 20A. Becausethe support spring portion 136 is elastically deformed in the verticaldirection by the coil portion 134 and own spring force of the supportspring portion 136 itself, the support spring portion 136 escapesdownward when contacted by the holding portion 58, and easily makes theholding portion 58 pass at the time of advancement and retraction of thecatheter operation member 20A.

Furthermore, the hub attachment portion 48 of the catheter operationmember 20A is formed of a pair of leg portions 138 adapted to clamp theouter peripheral surface of the catheter hub 14 as illustrated in FIG.12A. Additionally, the catheter operation member 20A includes a block140 projecting downward on a lower surface near the side edge 46 a on afront side of the pair of leg portions 138. The support spring portion136 is rotated anti-clockwise (elastically deformed) in a plane view bythe block 140 contacting the support spring portion 136 along withadvancement of the catheter operation member 20A. Therefore, the supportspring portion 136 is displaced to a position (second position P2) atwhich the support spring portion 136 is inserted into the slit 132 a onthe distal end side, and allows the catheter hub 14, catheter hubauxiliary member hub 24, and needle protection member 26 to pass.

Furthermore, at the time of assembling the catheter operation member 20Ato the housing 19A and when the catheter operation member 20A retractsagain, the needle protection member 26 and the like contact the supportspring portion 136 and rotates the support spring portion 136 in theproximal end direction as illustrated in FIG. 12B. Consequently, thesupport spring portion 136 is inserted into the slit 132 a on theproximal end side, and allows the catheter hub 14, catheter hubauxiliary member hub 24, and needle protection member 26 to pass.

As described above, in the catheter assembly 10A according to the firstmodified example also, effects same as the catheter assemblies 10 can beobtained. Particularly, the torsion spring 130 can stably support themultiple tube unit 11 until the torsion spring 130 is pressed by theblock 140, and the multiple tube unit 11 is effectively prevented frombeing warped. On the other hand, the torsion spring 130 can easily allowthe catheter hub 14, auxiliary member hub 24, and needle protectionmember 26 to pass along with pressing by the block 140. Meanwhile, theabove-described wing 116 and contacting projection 120 may be providedat the torsion spring 130.

Second Embodiment

Next, a catheter assembly 200 according to a second embodiment of thepresent invention will be described. In the catheter assembly 200, ashape of a needle hub 202 differs from a needle hub 18 of a catheterassembly 10 according to a first embodiment as illustrated in FIGS. 13and 14. More specifically, the needle hub 202 includes a housing 204 anda pair of arms 212 projecting from the housing 204 in a distal enddirection.

The housing 204 includes: a lower wall 206 having a pair of sideportions 32 a and a guide groove 32 b; and a pair of side walls 208projecting upward from both side portions of the lower wall 206, andforms a housing space 204 a on an inner side of the lower wall 206 andthe pair of side walls 208. A needle protection member 26 is housed inthe housing space 204 a of the housing 204 in the initial state.Meanwhile, the catheter assembly 200 does not include an auxiliarymember 22 and an auxiliary member hub 24 described above, but needlessto mention that the respective components may be also included.

Furthermore, as illustrated in FIG. 14, a needle holding member 210formed as a separate body from the housing 204 is fixed more on aproximal end side than the needle protection member 26 on the lower wall206 of the housing 204. The needle holding member 210 includes a holdingbase portion 210 a at a center portion in a width direction, ahorizontal plate 210 b projecting outward in the width direction fromthe vicinity of a lower side of the holding base portion 210 a andcontacting the pair of side portions 32 a, and a vertical plate 210 cprojecting upward from a projecting end of the horizontal plate 210 band contacting the pair of side walls 208. The holding base portion 210a fixes and holds a proximal end portion of an inner needle 16 at anupper portion thereof. Furthermore, a hook-like connecting portion notillustrated but adapted to hook an attachment hole 206 a (refer to FIG.13) of the lower wall 206 and firmly fix the needle holding member 210to the housing 204 is provided at a lower portion of the holding baseportion 210 a.

As illustrated in FIGS. 13 and 14, the pair of arms 212 (first arm 214and second arm 216) is connected to the pair of side walls 208 of thehousing 204, and extend directly in a distal end direction. A railportion 42 is provided at an inner surface of each of the pair of arms212, and a grip 212 a to be held by a user is provided on an outersurface of each of the arms. Furthermore, same as the first embodiment,in the first arm 214, an arrangement recessed portion 43, a pair ofbearing holes 43 a, 43 b, a window 43 c, and a locking recessed portion43 d are formed, and a support member 44 is rotatably attached.Meanwhile, the pair of arms 212 may be formed of a metallic material inorder to enhance rigidity (more specifically, to enhance an extendingposture), or an enhancement member such as a metal bar (not illustrated)may be embedded in the inside made of a resin material.

In the catheter assembly 200 according to the second embodiment, effectssame as the catheter assembly 10 can be obtained. More specifically, bysupporting a lower side of the multiple tube unit 11 with the supportmember 44 attached to the needle hub 202, a multiple tube unit 11 can beproperly prevented from being warped at the time of puncture. On theother hand, because the needle hub 202 includes the pair of arms 212,weight reduction of an entire assembly is achieved, and also mobility ofa catheter operation member 20 is improved by reducing friction at thetime of advancement and retraction of the catheter operation member 20.

SECOND MODIFIED EXAMPLE

Furthermore, a catheter assembly 220 (needle hub 222) according to asecond modified example illustrated in FIG. 15 includes the pair of arms212 same as the needle hub 202 according to the second embodiment buthas a structure further including a connection bridge portion 224 toprovide a bridge between the pair of the arms 212. The connection bridgeportion 224 is integrally formed with the pair of arms 212 on an innersurface at a lower position on a distal end sides of the pair of arms212. The connection bridge portion 224 has a length in a width directionof the lower wall 206 of the housing 204 and includes a pair of sideportions 32 a and a groove portion 32 b. Furthermore, an axial length ofthe connection bridge portion 224 corresponds to an installation area ofthe support member 44, and the connection bridge portion is set so asnot to expose a lower side of the support member 44.

Thus, because the needle hub 222 includes the connection bridge portion224 on the distal end sides of the pair of arms 212, an interval on thedistal end side and an entire portion of the pair of arms 212 can be setconstant. Therefore, even when the user grips the vicinity of the grip212 a of the pair of the arms 212, a shape of the needle hub 222 can beproperly maintained and advancing and retracting operation of thecatheter operation member 20 can be smoothly performed.

THIRD MODIFIED EXAMPLE

Furthermore, a catheter assembly 230 (needle hub 232) according to athird modified example illustrated in FIG. 16 has a structure includinga connection rod 324 to connect the distal end sides of the pair of arms212 instead of the above-described connection bridge portion 224. Theconnection rod 324 is a member made of, for example, a metallic materialand formed a shape of a cylindrical rod. The connection rod 324 providesa bridge having a length in a width direction of the lower wall 206between the pair of arms 212 in the same manner as the connection bridgeportion 224, thereby making the interval between the pair of arms 212constant.

In short, the needle hubs 222, 232 can adopt various kinds of structureswhich enhance the extending posture of the pair of arms 212 andsmoothens mobility of the catheter operation member 20. For example, theconnection bridge portion 224 and the connection rod 324 are provided atnot only the distal end sides of the pair of arms 212 but also middlepositions in the extending directions of the pair of arms 212.

What is claimed is:
 1. A catheter assembly comprising: a hollowcatheter; a catheter hub to which the catheter is fixed; an inner needleincluding a needle tip, the inner needle being detachably disposedinside of the catheter; a needle hub to which the inner needle is fixed;a catheter operation member configured to move the catheter relative tothe inner needle; and a support member disposed at the needle hub andconfigured to rotate about a rotation axis orthogonal to a longitudinaldirection of the assembly, wherein the support member includes a supportmain body portion that projects in a direction orthogonal to therotation axis of the support member and that is movable relative to theneedle hub between (i) a first position at which the support main bodyportion contacts and supports the catheter, and (ii) a second positionthat is a different position from the first position, at which thesupport main body portion does not contact the catheter.
 2. The catheterassembly according to claim 1, wherein: when the support member is atthe first position, the support main body portion projects in adirection orthogonal to a moving direction of the catheter, and when thesupport member is at the second position, the support main body portionprojects in a moving direction of the catheter operation member relativeto the needle hub.
 3. The catheter assembly according to claim 2,wherein the moving direction of the catheter operation member is anadvancement direction of the catheter operation member.
 4. The catheterassembly according to claim 2, wherein the moving direction of thecatheter operation member is a retraction direction of the catheteroperation member.
 5. The catheter assembly according to claim 1, whereinthe support main body portion is configured to be elastically deformedin a direction orthogonal to the moving direction of the catheter. 6.The catheter assembly according to claim 5, wherein the support mainbody portion further comprises: an upper surface configured to contactthe catheter held by the catheter operation member; and a contactingsurface configured to contact the catheter operation member, and whereinwhen the catheter operation member contacts the contacting surface ofthe support main body, the support main body is rotates from the firstposition.
 7. The catheter assembly according to claim 6, wherein thesupport main body portion further comprises a contacting projectionextending from the contacting surface in the axial direction of theassembly when the support main body portion is in the first position. 8.The catheter assembly according to claim 6, wherein the support memberfurther comprises: a cam portion having a first end and a second end,the cam portion configured to operate the support member; and a grooveportion extending from the first end of the cam portion to the secondend of the cam portion, the groove portion configured to house a sideedge of the catheter operation member in a slidale manner.
 9. Thecatheter assembly according to claim 8, wherein the cam portion furthercomprises: a first cam projection at the first end of the cam portion;and a second cam projection at the first end of the cam portion, whereinthe first cam projection is provided opposite the second cam projectionrelative to the rotation axis of the support member, and wherein thegroove portion is configured to house a side edge of the catheteroperation member.
 10. The catheter assembly according to claim 6,wherein the support main body portion is formed in a S-shape in a frontview.
 11. The catheter assembly according to claim 6, wherein thesupport member further comprises: a coil portion extending along therotation axis of the support member; and a projecting portion formed asthe support main body portion and projecting radially outward from thecoil portion, and wherein the support member is a torsion spring and thecoil portion is the axial portion of the support member.
 12. Thecatheter assembly according to claim 11, wherein the projecting portionis formed in a U-shape in a plane view.
 13. A catheter assemblycomprising: a hollow catheter; a catheter hub to which the catheter isfixed; an inner needle including a needle tip, the inner needle beingdetachably disposed inside of the catheter; a needle hub to which theinner needle is fixed; a catheter operation member configured to movethe catheter relative to the inner needle; and a support member disposedat the needle hub and configured to rotate about a rotation axisorthogonal to a longitudinal direction of the assembly, wherein thesupport member includes a support main body portion that projects in adirection orthogonal to the rotation axis of the support member and thatis movable relative to the needle hub between (i) a first position atwhich the support main body portion contacts and supports the catheter,(ii) a second position that is offset from the first position in anadvancement direction of the catheter operation member relative to theneedle hub, at which the support main body portion does not contact thecatheter, and (iii) a third position that is offset from the firstposition in a retraction direction of the catheter operation memberrelative to the needle hub, at which the support main body portion doesnot contact the catheter.
 14. The catheter assembly according to claim13, wherein, when the support member is at the first position, thesupport main body portion projects in a direction orthogonal to a movingdirection of the catheter.
 15. The catheter assembly according to claim14, wherein the support main body portion is configured to beelastically deformed in a direction orthogonal to the moving directionof the catheter.
 16. The catheter assembly according to claim 15,wherein the support main body portion further comprises: an uppersurface configured to contact the catheter held by the catheteroperation member; and a contacting surface configured to contact thecatheter operation member, and wherein when the catheter operationmember contacts the contacting surface of the support main body, thesupport main body is rotates from the first position.
 17. The catheterassembly according to claim 16, wherein the support main body portionfurther comprises a contacting projection extending from the contactingsurface in the axial direction of the assembly when the support mainbody portion is in the first position.
 18. The catheter assemblyaccording to claim 16, wherein the support member further comprises: acam portion having a first end and a second end, the cam portionconfigured to operate the support member; and a groove portion extendingfrom the first end of the cam portion to the second end of the camportion, the groove portion configured to house a side edge of thecatheter operation member in a slidale manner.
 19. The catheter assemblyaccording to claim 16, wherein the support member further comprises: acoil portion extending along the rotation axis of the support member;and a projecting portion formed as the support main body portion andprojecting radially outward from the coil portion, and wherein thesupport member is a torsion spring and the coil portion is the axialportion of the support member.